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Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients

Primary Purpose

Dental Plaque, Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)
manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®)
manual toothbrush (elmex® Inter X medium toothbrush)
manual toothbrush (elmex® Inter X medium toothbrush)
Sponsored by
Sebastian Zingler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque focused on measuring orthodontics, toothbrush, interdental brush, oral hygiene

Eligibility Criteria

11 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • no systemic diseases
  • orthodontic appliance (min. 10 completely erupted permanent teeth with brackets/bands)
  • informed consent

Exclusion Criteria:

  • presence of caries lesion
  • antibiotic therapy within the previous 6 months
  • diagnosis of early onset periodontitis

Sites / Locations

  • Department of Orthodontics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Plaque Indices
Gingival Indices

Secondary Outcome Measures

Periodontal parameters
Microbiological parameters
Molecularbiological parameters

Full Information

First Posted
May 16, 2008
Last Updated
February 21, 2012
Sponsor
Sebastian Zingler
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1. Study Identification

Unique Protocol Identification Number
NCT00681135
Brief Title
Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients
Official Title
Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients: Comparison of Different Toothbrushing Protocols
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sebastian Zingler

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether the use of a sonic toothbrush alone is more effective than two other toothbrushing protocols on dental plaque elimination in patients with fixed orthodontic appliances.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque, Gingivitis
Keywords
orthodontics, toothbrush, interdental brush, oral hygiene

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)
Other Intervention Name(s)
Philips Sonicare® FlexCare
Intervention Description
toothbrushing with a sonic toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
Intervention Type
Device
Intervention Name(s)
manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®)
Other Intervention Name(s)
elmex® Inter X medium toothbrush / interdental brush Curaprox®
Intervention Description
toothbrushing with a manual toothbrush and interdental brush and sealant coating (ProSeal™) of the enemal surface around the brackets
Intervention Type
Device
Intervention Name(s)
manual toothbrush (elmex® Inter X medium toothbrush)
Other Intervention Name(s)
elmex® Inter X medium toothbrush
Intervention Description
toothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
Intervention Type
Device
Intervention Name(s)
manual toothbrush (elmex® Inter X medium toothbrush)
Other Intervention Name(s)
elmex® Inter X medium toothbrush
Intervention Description
toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets
Primary Outcome Measure Information:
Title
Plaque Indices
Time Frame
every 4 weeks for 3 months
Title
Gingival Indices
Time Frame
every 4 weeks for 3 months
Secondary Outcome Measure Information:
Title
Periodontal parameters
Time Frame
every 4 weeks
Title
Microbiological parameters
Time Frame
every 4 weeks
Title
Molecularbiological parameters
Time Frame
every 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: no systemic diseases orthodontic appliance (min. 10 completely erupted permanent teeth with brackets/bands) informed consent Exclusion Criteria: presence of caries lesion antibiotic therapy within the previous 6 months diagnosis of early onset periodontitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J. Lux, Professor
Organizational Affiliation
Department of Orthodontics, University of Heidelberg
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Orthodontics
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

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Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients

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